Generally speaking, if a job or functional area can impact device quality, then the corresponding job descriptions and organizational chart must be controlled. Jobs and functional areas can be excluded if they can't possibly impact device quality. I explain further below.
For the FDA-regulated medical device jurisdiction, the FDA requires that we "establish" and maintain an adequate organizational structure to assure that devices are designed and produced in accordance with FDA's QS Regulation, and that we "establish" the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality. This is generally shown by way of an organizational chart. Remember that "establish" officially means "define, document, and implement". When FDA uses the term "establish", it generally requires control. Indeed, the preamble to the QS Regulation reminds us of this for the particular context of your question when FDA asserts that the established organizational structure needs to ensure that functions affecting device quality will be "controlled".
FDA also requires us to provide the independence and authority necessary to perform those tasks. This is generally shown within the aforesaid controlled organizational chart. While an "organizational chart" isn't specifically named by these FDA regulatory requirements, it is nonetheless the typical best practice. If you decide to employ a different modality than an organizational chart to meet the requirements, then it must still be controlled per the "established" criteria.
FDA in addition requires that we "establish" procedures for identifying training needs. This, combined with the aforesaid requirement that the established organizational structure shall ensure functions affecting device quality will be "controlled", generally points us to having controlled job descriptions.
Since FDA will soon be "converging" its QS Regulation with ISO 13485:2016 (look for a Final Rule to be published in the Federal Register later this year or in 2024), it is noteworthy that ISO 13485's corresponding requirements are generally the same. Indeed, ISO/TC 210 says that these requirements are usually achieved by means of documented position descriptions which include the scope of authorities, and by organizational charts. ISO/TC 210 says that, since this documentation forms part of the quality management system, then it "has to be controlled".
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 27-Sep-2023 05:54
From: Arvilla Trag
Subject: Should Job descriptions and Organizational charts be controlled ?
Good morning, Nivedha,
I have never seen job descriptions be controlled in the manner batch records, etc. are controlled, but a good HR department will make sure that each job title has a specific job description and specific requirements for training, education, and experience, rather than making it up on the fly.
Org charts are sometimes a controlled document, depending on the company. In a large organization it is typical for the org chart to show the names of executive management only, and everything below that is shown only as a job title, no names.
I hope this provided some help,
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Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United States
Original Message:
Sent: 26-Sep-2023 15:57
From: NIVEDHA SUBRAMANIAN
Subject: Should Job descriptions and Organizational charts be controlled ?
HELLOO RAPS community members,
I considered asking for advice on the following:
- Is it mandatory to control Job descriptions for each position in a medical device organization ?
- Should we control the Organizational chart ? If yes, Is it required to include all the existing job roles within the company?
- How frequently should we review and update these documents?
Would appreciate your comments!
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NIVEDHA SUBRAMANIAN
Toronto ON
Canada
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